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| Quasi-cluster randomized trial of a six-month low-intensity group-based resistance exercise for hemodialysis patients on depression and cognitive function: a 12-month follow-up |
| Nakamura-Taira N, Horikawa N, Oka F, Igarashi Y, Kobayashi S, Kato S, Enomoto T, Kimura H, Watanabe Y, Kumada T, Matsuyama K, Matsuoka N, Yoshimasu H |
| Health Psychology and Behavioral Medicine 2021;9(1):741-760 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: No; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVE: This study aimed to examine the effects of a six-month group-based low-intensity resistance exercise program on depression and the cognitive function of hemodialysis patients. METHOD: We conducted a quasi-cluster randomized, open-label controlled study from October 2017 to December 2018. Forty-two patients undergoing hemodialysis completed the trial over six months; half participated in the resistance exercise group (n = 21, mean 74.90 years of age, SD 2.23, 66.67% female) and the other half were in a stretching control group (n = 21, mean 72.57 years of age, SD 2.26, 28.57% female). Depressive symptoms and cognitive function were the primary outcome measures. Behavioral and psychological problems associated with cognitive decline (NPI-Q), subjective insomnia, and exercise self-efficacy were secondary outcomes. Outcomes were measured at baseline, three-month (mid-intervention), six-month (end of intervention), and 12-month (six months after intervention) follow-ups. Linear mixed model analyses were used to determine short-term (immediately after intervention) and long-term (six months after intervention) effects. RESULTS: In depression, cognitive function, and the NPI-Q, there were no significant effects. In subjective insomnia, a short-term group-by-time interaction in the intervention group compared to the control group was found (ES 0.43). However, the effect had disappeared by the 12-month follow-up. In exercise self-efficacy, short- and long-term group-by-time interactions were found. A significant short-term increase in the resistance exercise and a significant decrease in the stretching control was observed (ES -0.83). However, the effect was weakened in the long term (ES -0.38). CONCLUSION: The results showed that low-intensity group resistance exercise would reduce subjective insomnia and improve exercise self-efficacy, but the effect was not maintained by six months after the program. TRIAL REGISTRATION: This study was registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN000029372). UMIN Japan identifier UMIN000029372.
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